Blue light flexible cystoscopy with hexaminolevulinate in non-muscle-invasive bladder cancer: review of the clinical evidence and consensus statement on optimal use in the USA \u2014 update 2018

Yair Lotan,Sanjay Patel,Siamak Daneshmand,Michael O’Donnell,Per-Uno Malmström,Kamal Pohar,Trinity J Bivalacqua,William Huang,Gary Steinberg,Edouard Trabulsi,James Mckiernan,Angela Smith,Ashish M Kamat,Michael Woods,Tracy Downs,Badrinath Konety,Alexander Sankin,Matthew Resnick,Jeffrey Jones

doi:10.1038/s41585-019-0184-4

Abstract

Blue light cystoscopy (BLC) with hexaminolevulinate (HAL) during transurethral resection of bladder cancer improves detection of non-muscle-invasive bladder cancer (NMIBC) and reduces recurrence rates. Flexible BLC was approved by the FDA in 2018 for use in the surveillance setting and was demonstrated to improve detection. Results of a phase III prospective multicentre study of blue light flexible cystoscopy (BLFC) in surveillance of intermediate-risk and high-risk NMIBC showed that 20.6% of malignancies were identified only by BLFC. Improved detection rates in the surveillance setting are anticipated to lead to improved clinical outcomes by reducing future recurrences and earlier identification of tumours that are unresponsive to therapy. Thus, BLFC has a role in surveillance cystoscopy, and determining which patients will benefit from BLFC and optimal and cost-effective ways of incorporating this technology into surveillance cystoscopy must be developed.

Highlights

Blue light cystoscopyBLC is an FDA-approved photodynamic diagnostic technique that serves as an adjunct to White light cystoscopy (WLC) to improve visualization and treatment of bladder cancer[9]
The meeting consisted of 17 specialists in bladder cancer who are experienced with the use of BLC, including 14 who participated in the phase III blue light flexible cystoscopy (BLFC) for surveillance trial[10]
Tumours in 9 of the 26 patients were found using blue light alone, and, of these patients, 0 had positive cytology, 1 had suspi cious cytology results, 4 had atypical results, 3 had negative cytology and 1 had missing results. These findings highlight the need for enhanced cystoscopy, as relying on cytology to detect carcinoma in situ (CIS) missed by WLC is likely to be inadequate for finding most cancers[33]

Summary

Methods

For purposes of this Consensus Statement, a meeting was held at the AUA Meeting on 17 May 2018. The meeting consisted of 17 specialists in bladder cancer who are experienced with the use of BLC, including 14 who participated in the phase III BLFC for surveillance trial[10]. Reviewed the highest level of evidence involving BLC for TURBT and BLFC for surveillance in the outpatient setting as well as future directions. The survey results were discussed and a consensus was developed regarding optimal use of BLFC for surveillance on the basis of current knowledge. During drafting of this Consensus Statement, the authors performed a PubMed search using the terms “bladder cancer”, “hexaminolevulinate blue light cystoscopy”, “hexvix”, “cysview” and “photodynamic diagnosis” and reviewed currently available guidelines on NMIBC

Background

Pfloosotrerior

Findings

Conclusions